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Clinical Policy Bulletin:
Macular/Foveal Translocation
Number: 0409


Policy

Aetna considers macular/foveal translocation experimental and investigational for age-related macular degeneration (AMD) and for all other indications because the safety and effectiveness of this procedure has not been established in the medical literature.

See also CPB 0111 - Indocyanine Green AngiographyCPB 0490 - Transpupillary Thermal TherapyCPB 0594 - Visudyne (Verteporfin) Photodynamic Therapy, and CPB 0609 - Laser Photocoagulation of Drusen.



Background

Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) can result in legal blindness.  Currently, there is no satisfying treatment for CNV.  Photocoagulation has been shown to be effective, but it causes a decrease in vision immediately after treatment.  Surgical removal of the choroidal neovascular membrane is effective in selected cases, but it restores useful vision for reading (20/40 or better) only in a small number of cases.

Macular/foveal translocation is a technique first developed in the 1980s to treat this condition following surgical removal of subfoveal choroidal neovascular membrane.  This procedure entails translocation of the fovea to a macular region with intact/healthier retinal pigment epithelium before permanent retinal damage occurs.  Available data in the peer-reviewed medical literature have not demonstrated the safety and effectiveness of this procedure.  Charles (2001) has commented that whereas the natural history of subfoveal CNV never results in total blindness, this outcome is “all too frequent” with macular translocation and submacular surgery.  Further investigations are warranted to refine this procedure -- determining the amount of translocation needed, and reducing the incidence of complications such as retinal detachment, proliferative vitreoretinopathy, corneal astigmatism, cataract, metamorphopsia, diplopia and tilted image, loss of peripheral visual field, as well as recurrence of CNV.

In a retrospective analysis of non-randomized interventional clinical study, Glacet-Bernard and co-workers (2007) compared the results of limited macular translocation and photodynamic therapy (PDT) in subfoveal CNV attributable to pathologic myopia with a 24-month follow-up.  These investigators performed review of 66 consecutive patients: 34 myopic eyes with subfoveal CNV treated by PDT and 32 operated on with the translocation technique.  Translocation was considered principally when the lesion size was adequate (nasal inferior margin of the membrane less than half a disk diameter away from the center of the fovea) with duration of symptoms of less than 4 months.  Main outcome measure was the post-operative change in visual acuity.  In the translocation group, mean gain in visual acuity was greater than in the PDT group (+2.8 lines and -1.8 lines, respectively, p = 0.001).  In the translocation group, 55 % of eyes gained 3 lines or more at 2 years compared with 10 % in the PDT group.  Sixty percent of eyes in the translocation group versus 40 % in the PDT group had an improvement of at least five letters.  Mean foveal displacement after translocation was 906 mum; post-operative complications included retinal detachment (3 eyes), macular fold (1 eye), and transient diplopia (4 eyes).  In young patients, the post-operative gain was better in both groups.  In the translocation group, mean survival time for CNV recurrence was 40 months for patients younger than 40 years and 20 months for older patients.  The authors concluded that translocation showed better results than PDT at 2 years.  Moreover, they stated that further studies are needed to confirm these findings.

In a pilot study, Gelisken and colleagues (2007) compared full macular translocation (FMT) with PDT in the treatment of neovascular AMD.  A total of 50 eyes of 50 patients were assigned to either FMT or PDT.  Baseline and control examinations in 3-monthly intervals over a 12-month period included standardized protocol refraction, visual acuity testing and fluorescein angiography.  Primary outcome measurements were made to establish the change in distant visual acuity from the baseline to the 12-month examination.  The statistical analyses were carried out on the intent-to-treat principle.  The improvement of 1 or more lines on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was 56 % (14/25) of the eyes in the FMT and 16 % (4/25) of the eyes in the PDT arm (p = 0.007).  Twenty eyes (80 %) in the FMT and 16 eyes (64 %) in the PDT group had less than 3 ETDRS lines of vision loss (p = 0.35).  Retinal detachment (6 eyes) and diplopia (5 patients) were recorded in the FMT group.  None of the eyes treated in the FMT group had phtysis.  The authors concluded that this pilot study showed that no statistically significant difference existed between the FMT and PDT in terms of the vision loss of less than 3 ETDRS lines in eyes with neovascular AMD.  The chance of vision improvement was significantly higher for the patients in the FMT group.  However, the authors stated that in the era of promising therapy with anti-vascular endothelial growth factor for neovascular AMD, FMT should not be offered as a standard primary procedure for neovascular AMD.  These investigators (Luke et al, 2007) noted that FMT and PDT can achieve a stabilization in vision-related quality of life (QOL), in which FMT was superior to the PDT after 1 year.  The discrepancy between the amount of patients with an increased visual acuity after FMT and a moderate improvement in QOL might be caused by the onset of complications related to this surgical procedure.  They noted that besides visual acuity, the impact of therapy-related complications has to be taken into consideration when evaluating new therapeutic concepts in exudative AMD.

Nguyen and associates (2007) evaluated the power of magnification required, reading performance with low-vision aids and vision-related QOL with reference to reading ability and ability to carry out day-to-day activities in patients after macular translocation.  This study included 15 patients who had undergone macular translocation with 360-degree peripheral retinectomy.  The mean length of follow-up was 19.2 +/- 10.8 months (median of 11 months).  At the final examination, the impact of visual impairment on reading ability and QOL was assessed according to a modified 9-item questionnaire in conjunction with a comprehensive clinical examination, which included assessment of best corrected visual acuity (BCVA), the magnification power required for reading, use of low-vision aids and reading speed.  Patients rated the extent to which low vision restricted their ability to read and participate in other activities that affect QOL.  Responses were scored on a scale of 1.0 (optimum self-evaluation) to 5.0 (very poor).  In the operated eye, overall mean post-operative BCVA (distance) was not significantly better than mean pre-operative BCVA (0.11 +/- 0.06 and 0.15 +/- 0.08, respectively; p = 0.53).  However, 53 % of patients reported a subjective increase in visual function after treatment.  At the final visit, the mean magnification required was x 7.7 +/- 6.7.  A total of 60 % of patients needed optical magnifiers for reading and in 40 % of patients closed-circuit TV systems were necessary.  All patients were able to read newspaper print using adapted low-vision aids at a mean reading speed of 71 +/- 40 words per minute.  Mean self-reported scores were 3.2 +/- 1.1 for reading, 2.5 +/- 0.7 for day-to-day activities and 2.7 +/- 3.0 for outdoor walking and using steps or stairs.  Patients' levels of dependency were significantly correlated with scores for reading (p = 0.01), day-to-day activities (p < 0.001) and outdoor walking and using steps (p = 0.001).  The authors concluded that the evaluation of self-reported visual function and vision-related QOL in patients after macular translocation is necessary to obtain detailed information on treatment effects.  These results indicated improvement in patients' subjective evaluations of visual function, without significant improvement in visual acuity.  The post-operative clinical benefits of treatment coincide with subjective benefits in terms of reading ability, QOL and patient satisfaction.

Luke et al (2009) reported the outcome of BCVA, near visual acuity (NVA), contrast sensitivity (CS) and vision-related quality of life (VRQOL) in patients 2 years after undergoing PDT or FMT for the treatment of neovascular AMD.  A total of 50 patients with predominantly classic subfoveal CNV secondary to AMD were randomized to PDT or FMT.  Best-corrected visual acuity was determined according a standardized protocol with ETDRS charts; NVA were calculated after testing with SNAB (Swiss National Association of and for the Blind) visual acuity cards; and CS was measured with Pelli-Robson charts.  The 39-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25 plus supplement) was performed.  Primary end points were the changes of BCVA, NVA, CS and VRQOL at 24-month examination.  A stabilization of BCVA (+0.3 letters) was found in the FMT group, whereas a decrease of more than 12 letters (-12.6 letters) was found in the PDT group (p = 0.052).  Mean NVA improved by 7.0 letters in the FMT group and was superior to the PDT group (-9.6 letters, p = 0.036), while mean CS showed a time-dependent decrease in both treatment groups (FMT: -3.3 letters, PDT: -3.8 letters, p = 0.726).  Considering the results of the VRQOL scores, the improvement of the subscales scores for general vision (p = 0.015), mental health (p = 0.028) and near activity (p = 0.020) were significantly higher in the FMT group.  The authors concluded that FMT can stabilize BCVA and improve NVA over a period of 2 years in patients with subfoveal classic CNV secondary to neovascular AMD, whereas a decrease of BCVA and NVA was found in the PDT group; and CS did not differ between FMT and PDT.  A significant increase of VRQOL scores was only found in the FMT group and not in the PDT group.  They stated that FMT appears to be a therapeutic approach that can increase visual function resulting in an improvement of patient's VRQOL, but exhibits a higher number of severe complications compared to PDT.

In a retrospective, interventional case series, Yamada and colleagues (2010) reported the long-term (greater than 5 years) results of FMT in patients with CNV.  This study involved 32 eyes of 32 patients who had undergone FMT for CNV.  The median follow-up was 6.5 years (range of 5.2 to to 7.7 years).  These investigators assessed the BCVA, fundus examination results obtained before and 1 and 5 years after operation, and post-operative complications.  At the 1-year follow-up, foveal retinal pigment epithelium atrophy was observed in only 3 eyes (12 %), and the mean logarithm of the minimal angle of resolution (logMAR) visual acuity (VA) at that time (1.39 +/- 0.67) was not significantly changed from that before surgery (logMAR, 1.31 +/- 0.66) in 25 eyes with AMD.  However, at 5-year follow-up, foveal retinal pigment epithelium atrophy increased (18 eyes; 72 %), and final mean logMAR VA (1.88 +/- 0.76) was significantly lower (p < 0.01).  Five eyes with myopic CNV maintained their VA from before operation (mean logMAR, 0.88 +/- 0.35) until final follow-up (mean logMAR, 0.73 +/- 0.31).  The final VA was significantly better in myopic CNV than in exudative AMD on multiple regression analysis (p = 0.019).  The authors concluded that long-term follow-up of FMT showed that the final VA was poor in AMD, but relatively better in myopic CNV.

In a Cochrane review on macular translocation for neovascular AMD, Eandi et al (2008) concluded that there is insufficient evidence from randomized controlled trials on the effectiveness of macular translocation, which is also not free of important risks.  Furthermore, this technique is difficult to perform and a long surgical training is required.  The authors stated that future studies might include patients with small neovascular lesions that failed to respond to current pharmacological therapies and are willing to accept the risks associated with surgery to try to improve visual acuity.

Interventional Procedure Guidance from the National Institute for Health and Clinical Excellence (NICE, 2010) concluded that current evidence for macular translocation for wet AMD "shows that this procedure is efficacious only in a proportion of patients and that there is a potential for serious adverse events.  Therefore the procedure should only be used with special arrangements for clinical governance, consent and audit or research."

An UpToDate review on "Age-related macular degeneration: Treatment and prevention" (Arroyo, 2012) states that "[m]acular translocation surgery is experimental and involves moving the macula to a less diseased area of the retina in patients with subfoveal choroidal neovascularization.  The advent of effective pharmacologic therapy has limited the use of this surgical modality to patients with large submacular hemorrhages.  The surgical risks are substantial (retinal detachment, proliferative vitreoretinopathy, diplopia)".  (Affirmed Febraury 2013)

 
CPT Codes / HCPCS Codes / ICD-9 Codes
There are no specific CPT or HCPCS codes for macular/foveal translocation:
ICD-9 codes not covered for indications listed in the CPB (not all inclusive):
362.16 Retinal neovascularization NOS
362.50 - 362.52 Macular degeneration (senile)


The above policy is based on the following references:
  1. Lewis H, Kaiser PK, Lewis S, Estafanous M. Macular translocation for subfoveal choroidal neovascularization in age-related macular degeneration: A prospective study. Am J Ophthalmol. 1999;128(2):135-146.
  2. de Juan E Jr., Loewenstein A, Bressler NM, Alexander J. Translocation of the retina for management of subfoveal choroidal neovascularization II: A preliminary report in humans. Am J Ophthalmol. 1998;125(5):635-646.
  3. Ohji M, Fujikado T, Saito Y, et al. Foveal translocation: A comparison of two techniques. Semin Ophthalmol. 1998;13(1):52-62.
  4. Wolf S, Lappas A, Weinberger AW, Kirchhof B. Macular degeneration for surgical management of subfoveal choroidal neovascularization in patients with AMD: First results. Grafes Arch Clin Exp Ophthalmol. 1999;237(1):51-57.
  5. Au Eong KG, Pieramici DJ, Fujii GY, et al. Macular translocation: Unifying concepts, terminology, and classification. Am J Ophthalmol. 2001;131(2):244-253.
  6. Fujii GY, de Juan E Jr, Pieramici DJ, et al. Inferior limited macular translocation for subfoveal choroidal neovascularization secondary to age-related macular degeneration: 1-year visual outcome and recurrence report. Am J Ophthalmol. 2002;134(1):69-74.
  7. Aisenbrey S, Lafaut BA, Szurman P, et al. Macular translocation with 360 degrees retinotomy for exudative age-related macular degeneration. Arch Ophthalmol. 2002;120(4):451-459.
  8. Hamelin N, Glacet-Bernard A, Brindeau C, et al. Surgical treatment of subfoveal neovascularization in myopia: Macular translocation vs surgical removal. Am J Ophthalmol. 2002;133(4):530-536.
  9. Arnold JJ, Sarks SH. Age related macular degeneration. Extracts from 'Clinical Evidence.' Br Med J. 2000;321:741-744. Available at: http://bmj.com/cgi/content/full/321/7263/741. Accessed December 9, 2002.
  10. Charles S. Neovascular membranes, subretinal. eMedicine Ophthalmology Topic 681. Omaha, NE: eMedicine.com; updated August 1, 2001. Available at: http://www.emedicine.com/oph/topic681.htm. Accessed December 9, 2002.
  11. Abdel-Meguid A, Lappas A, Hartmann K, et al. One year follow up of macular translocation with 360 degree retinotomy in patients with age related macular degeneration. Br J Ophthalmol. 2003;87(5):615-621.
  12. Luke C, Alteheld N, Aisenbrey S, et al. Electro-oculographic findings after 360 degrees retinotomy and macular translocation for subfoveal choroidal neovascularisation in age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2003;241(9):710-715.
  13. Park CH, Toth CA. Macular translocation surgery with 360-degree peripheral retinectomy following ocular photodynamic therapy of choroidal neovascularization. Am J Ophthalmol. 2003;136(5):830-835.
  14. Royal College of Ophthalmologists (RCO). Age-related macular degeneration. Guidelines. London, UK: RCO; February 2000.
  15. National Institute for Clinical Excellence (NICE). Macular translocation for age-related macular degeneration. Interventional Procedure Guidance 48. London, UK: NICE; March 2004.
  16. Koh SS, Arroyo J. Macular translocation with 360-degree retinotomy for treatment of exudative age-related macular degeneration. Int Ophthalmol Clin. 2004;44(1):73-81.
  17. Ng EW, Fujii GY, Au Eong KG, et al. Macular translocation in patients with recurrent subfoveal choroidal neovascularization after laser photocoagulation for nonsubfoveal choroidal neovascularization. Ophthalmology. 2004;111(10):1889-1893.
  18. Au Eong KG. Initial experience of macular translocation in Singapore - one-year results. Ann Acad Med Singapore. 2004;33(5):641-648.
  19. Mateo C, Moreno J, Rosales G, et al. Two-year results of macular translocation with scleral infolding in myopic choroidal neovascularisation. Semin Ophthalmol. 2004;19(1-2):29-42.
  20. Ohno-Matsui K, Yoshida T. Myopic choroidal neovascularization: Natural course and treatment. Curr Opin Ophthalmol. 2004;15(3):197-202.
  21. Bylsma GW, Guymer RH. Treatment of age-related macular degeneration. Clin Exp Optom. 2005;88(5):322-334.
  22. Chan WM, Ohji M, Lai TY, et al. Choroidal neovascularisation in pathological myopia: An update in management. Br J Ophthalmol. 2005;89(11):1522-1528.
  23. Glacet-Bernard A, Benyelles N, Dumas S, et al. Photodynamic therapy vs limited macular translocation in the management of subfoveal choroidal neovascularization in pathologic myopia: A two-year study. Am J Ophthalmol. 2007;143(1):68-76.
  24. Maloney SC, Godeiro KD, Odashiro AN, Burnier MN Jr. Current and emerging concepts in the management of neovascular age-related macular degeneration. Cardiovasc Hematol Agents Med Chem. 2007;5(2):147-154.
  25. Gelisken F, Voelker M, Schwabe R, et al. Full macular translocation versus photodynamic therapy with verteporfin in the treatment of neovascular age-related macular degeneration: 1-year results of a prospective, controlled, randomised pilot trial (FMT-PDT). Graefes Arch Clin Exp Ophthalmol. 2007;245(8):1085-1095.
  26. Luke M, Ziemssen F, Bartz-Schmidt KU, Gelisken F. Quality of life in a prospective, randomised pilot-trial of photodynamic therapy versus full macular translocation in treatment of neovascular age-related macular degeneration -- a report of 1 year results. Graefes Arch Clin Exp Ophthalmol. 2007;245(12):1831-1836.
  27. Nguyen NX, Besch D, Bartz-Schmidt K, et al. Reading performance with low-vision aids and vision-related quality of life after macular translocation surgery in patients with age-related macular degeneration. Acta Ophthalmol Scand. 2007;85(8):877-882.
  28. Polisena J, Mierzwinski-Urban M. Macular translocation surgery for patients with age-related macular degeneration: Clinical and cost-effectiveness review. Health Technology Inquiry Service (HTIS). Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); November 8, 2007.
  29. Eandi CM, Giansanti F, Virgili G. Macular translocation for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2008;(4):CD006928.
  30. Lüke M, Ziemssen F, Völker M, et al. Full macular translocation (FMT) versus photodynamic therapy (PDT) with verteporfin in the treatment of neovascular age-related macular degeneration: 2-year results of a prospective, controlled, randomised pilot trial (FMT-PDT). Graefes Arch Clin Exp Ophthalmol. 2009;247(6):745-754.
  31. Yamada Y, Miyamura N, Suzuma K, Kitaoka T. Long-term follow-up of full macular translocation for choroidal neovascularization. Am J Ophthalmol. 2010;14(3):453-457.
  32. National Institute for Health and Clinical Excellence (NICE). Macular translocation with 360° retinotomy for wet age related macular degeneration. Interventional Procedure Guidance 340. London, UK: NICE; May 2010.
  33. National Institute for Health and Clinical Excellence (NICE). Limited macular translocation for wet age-related macular degeneration. Interventional Procedure Guidance 339. London, UK: NICE; May 2010. 
  34. Chen FK, Patel PJ, Uppal GS, et al. Long-term outcomes following full macular translocation surgery in neovascular age-related macular degeneration. Br J Ophthalmol. 2010;94(10):1337-1343.
  35. Polito A, Cereda M, Romanelli F, Pertile G. Macular translocation with 360 degrees retinotomy for management of retinal pigment epithelial tear: Long-term results. Br J Ophthalmol. 2011;95(1):74-78.
  36. Arroyo JG. Age-related macular degeneration: Treatment and prevention. Last reviewed February 2012. UpToDate Inc. Waltham, MA.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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